Intrauterine device and inserter for the same

ABSTRACT

An inserter for placing a T-shaped intrauterine device inside a patient&#39;s uterus and a T-shaped intrauterine device are disclosed. The inserter includes a sleeve part and a plunger part, the sleeve part includes a tube and a first engaging member and the plunger part includes a rod, a handle attached to the rod and a second engaging member. The first and the second engaging members are configured for reversibly engaging the sleeve part and the plunger part to temporarily lock the relative position between the tube and the rod. The T-shaped intrauterine device includes a pair of wings having a relaxed extended configuration and a contracted folded configuration and an elongated contraceptive body suspended from a junction between the wings.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to an intrauterine device (IUD)and to an inserter for placing the same. More specifically the inventionrelates to a combination of a one-hand-held inserter for positioning aT-shaped intrauterine device and to a T-shaped intrauterine device thatare designed to make insertion easier while minimizing patient'sdiscomfort and pain.

2. Discussion of the Related Art

Intrauterine devices and inserters for the same are well known. Anintrauterine device (IUD) is a reversible, long acting, contraceptivedevice that is placed inside the uterus and can remain there for a fewyears. At any time that the woman plans to have a child, it can beeasily removed by a clinician. Many women find the IUD to be veryconvenient because unlike oral contraceptives which require dailyattention, an intrauterine device requires little action once it is inplace.

Over the years various types of intrauterine devices have been proposedand applied. At present there are two types of IUDs in use: acopper-based IUD and a hormonal IUD. Copper-based IUDs are available inthe T-framed shape or as frameless IUDs. The T-shaped IUDs comprise aT-shaped plastic frame having an elongated body partly wrapped by acopper coil and a pair of flexible transverse arms that hold the IUD inplace near the top of the uterus. The IUD is inserted into the uteruswith the transverse arms folded to facilitate the insertion through thecervical canal. Once the device is positioned inside the uterus, thearms are released and assume their transverse orientation. Depending onthe particular device, the arms are either folded backward against thestem, as for example in TC-380A. (e.g., ParaGard®), or are folded in theforward direction against each other as in Nova-T type IUDs. Theframeless copper IUD (e.g., GyneFix®) does not contain a T-shape framebut is a loop that holds several copper tubes and is anchored into theuterus fundus by a suture.

Of particular interest of the present invention are hormonal IUDs (alsoknown as intrauterine system—IUS) which contain reservoir of hormonethat is gradually released into the uterine cavity. At present there isonly one hormonal IUD available for use, the T-frame LNG-20 distributedby Schering Og under the name Mirena®. It consists of a flexible plasticT-shaped frame surrounded by a hormone (levonorgestrel) cylinder.Hormonal IUDs have other benefits besides being contraceptive and mayalso be given for treatment of hormonal disorders and for hormonereplacement therapy. Compared to copper-based IUDs such as for examplethe Nova-T, the LNG-20 is bulkier, having a body of larger diameter. Itsinsertion procedure requires more expertise and may be associated withmore discomfort and pain to the patient.

The insertion and removal of an IUD is a medical procedure performed bya physician. The IUD is inserted through the cervix and into the uterinecavity by means of an inserter that typically includes an insertion tubethat accommodates the IUD and a plunger. For T-shaped IUD the lateralarms are folded prior to insertion. An IUD typically also includes astring extending from its bottom end, which serves for monitoring theIUD and for facilitating its removal.

IUD is one of the most effective reversible contraceptive methods andhas certain advantages over other birth control means with respect tocost-effectiveness and convenience, and because it is a long-term,reversible method, it can meet the needs of many women. However, despitethese advantages, IUDs are widely used only in a few large countries,such as China, Egypt, and Vietnam, and are little used in mostcountries. In the United States, for example, only about 2% of women whouse birth control means, use IUDs.

One of the reasons for IUDs not being more popular is the fear of thediscomfort and pain associated with the insertion procedure. Inaddition, the general practice to perform insertion during the menstrualperiod may add to the discomfort felt by potential users. Further,although there is no minimum age for using IUD, it is often believedthat IUDs should not be given to young women or to women who have neverbeen pregnant.

There is therefore a continuous need to improve intrauterine devices andinsertion procedure that may lead to greater acceptability and use ofIUDs.

Accordingly, it is the general object of the invention to simplify IUDinsertion procedure and to minimize the patient's discomfort and risk ofcomplications during and after insertion.

In particular, it is an object of the present invention to provide aninserter for an intrauterine device that is easier to manipulate, thatwill make insertion procedure easier to the physician and less painfulto the patient and that is simple to manufacture and to use.

It is another object of the present invention to provide an intrauterinedevice that is easier to insert and remove, that has a simple structureand is easy and inexpensive to manufacture.

SUMMARY OF THE PRESENT INVENTION

One aspect of the present invention is an inserter for placing aT-shaped intrauterine device inside a patient's uterus. The insertercomprises a sleeve part and a plunger part. The sleeve part comprises anopen tube dimensioned to receive the contraceptive body of theintrauterine device and a first engaging member. The plunger partcomprises a rod, a handle attached to one end of the rod and a secondengaging member. The first and second engaging members are configuredfor reversibly and slidably engaging the sleeve part and the plungerpart when the rod is inserted into the tube, and when the sleeve partand the plunger part are engaged, to temporarily lock the relativeposition between the tube and the rod. In accordance with an embodimentof the invention, the first engaging member comprises a disk attached toone open end of the tube, the disk having a central opening aligned withthe open end and two opposite recesses and the second engaging membercomprises two resilient arms dimensioned to be received in the twoopposite recesses of the disk. The sleeve part and the plunger part canbe separated into two separate parts.

Another aspect of the invention is a T-shaped intrauterine devicecomprising a transverse member and an elongated contraceptive bodysuspended from said transverse member. The transverse member comprises apair of wings having a relaxed configuration in which the wings extendedlaterally and a contracted folded configuration in which the wings arefolded against each other. Preferably the wings are convex. Optionally,the elongated contraceptive body is suspended from the transverse bymeans of a string connected to the junction zone between the two wings.Optionally, the string is threaded through an eyelet in the junctionzone. The string may be connected to an eyelet at provided at one end ofthe elongated contraceptive body or may run along the centrallongitudinal axis of the elongated contraceptive body. Optionally theintrauterine device further comprises at least one removal stringsuspended from the bottom end thereof. The elongated contraceptive bodymay comprise a reservoir of at least one contraceptive agent and asustained release means adapted for providing a sustained release of thecontraceptive agent. The contraceptive agent may be a progesteroneanalog, e.g., levonorgestrel. Alternatively the elongated contraceptivebody may comprise copper.

Yet, further aspects of the invention are a combination of the inserterand intrauterine device of the invention and a kit for the positioningof an intrauterine device inside a patient's uterus that includes thecombination under sterile packaging.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description taken in conjunction with thedrawings in which:

FIG. 1 is a schematic side view of the plunger part of an inserter forpositioning an intrauterine device, in accordance with an embodiment ofthe invention;

FIGS. 2A and 2B are side and bottom views, respectively, of the sleevepart of an inserter for positioning an intrauterine device, inaccordance with an embodiment of the invention;

FIG. 3 is a schematic illustration of an intrauterine device inaccordance with an embodiment of the invention;

FIG. 4 is a schematic illustration of an intrauterine device inaccordance with another embodiment of the invention;

FIG. 5A is a broken view demonstrating the assembled inserter and theintrauterine device in a storage position;

FIG. 5B is a broken view illustration the intrauterine device and theinserter in a pre-inserting position; and

FIG. 5C is a broken view illustrating the intrauterine device and theinserter after the intrauterine device is released from the inserter andbefore the inserter is withdrawn.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to the drawings, FIGS. 1 and 2 depict the disassembled partsof an inserter for an intrauterine device in accordance with anembodiment of the invention. The assembled inserter, generallydesignated 10, is depicted in FIGS. 5A to 5C. Inserter 10 comprises asleeve part 2 and a plunger part 3. Parts 2 and 3 can be easilyassembled manually with no need for any tools and similarly can beeasily disassembled into two separate parts to facilitate the removal ofthe inserter after the intrauterine device is positioned correctlyinside the uterus.

Plunger part 2 comprises a thin rod 22 and a handle 24 fixedly attachedto one end of the rod. Handle 24 comprises an elongated portion 26 tofacilitate gripping by hand and two opposite resilient arms 28 extendingupwardly in the direction of and on opposite sides of rod 22. Arms 28are configured as tweezers arms that can bend inwardly toward eachother. Rod 22 and handle 24 are preferably made from a rigidsterilizable polymeric material such as polyethylene or the like. Rod22, due to its small diameter/length ratio can easily flex to assume anycurvature. Preferably part 2 is formed as a one integral piece, forexample by mould injection. Alternatively, rod 22 can be attached tohandle 24 by any other method including heat fusing, adhering and thelike, or can be inserted into a bore drilled or otherwise formed inhandle 24.

Sleeve part 3 comprises a tube 32 provided with a disk 34 at itsproximal end. Tube 32 is a hollow tube made of medical gradesterilizable semi-rigid polymeric material such as polyethylene,polypropylene and the like. The inner diameter of the tube isdimensioned to receive the contraceptive body of a T-shaped intrauterinedevice, such as the devices depicted in FIGS. 3 and 4. The distal(upper) part of tube 32 is slightly curved to better adapt to thecurvature of the uterus. The tube may be further bent before insertionand after examining the curvature of the uterus. Tube 32 may be furtherprovided with a movable marking ring 35 which can slide along the tube.Ring 35 serves to mark the correct depth of insertion, i.e., the lengthof the uterine lumen, measured prior to insertion, as is well known inthe art. Tube 32 may also include imprinted scaling marks (not shown) tofacilitate positioning of ring 35. As shown in FIG. 2B, disk 34comprises a central opening 36, substantially of the same diameter asthe inner diameter of tube 32 and two opposite recesses 38. Recesses 38are dimensioned to receive arms 28 of plunger 2.

Inserter 10 is assembled by inserting rod 22 of plunger 2 into tube 32through opening 36 of disk 34 and forcing arms 28 of the plunger intorecesses 34 of the disk, such that the tube can slide along the arms. Asmentioned above, arms 28 are resilient and act like tweezers. When nopressure is applied on the arms, sleeve 3 can slide up and down arms 28to assume any desired relative position between plunger and sleeve. Whenarms 28 are pressed against disk 36, the sleeve is locked to the plungerto maintain their relative position. Thus, disk 34 and arms 28 serve asengaging members that allow not only to easily assemble/disassemble theplunger and sleeve but also to easily lock/release their relativeposition. The inward surface of arms 28 may be smooth or may be toothed,as depicted in FIG. 1, to enhance the grip of disk 34 by arms 28.Alternatively, recesses 38 may be each provided with a small protrusionand arms 28 may be each provided with a complementary longitudinal slotrunning along the inward surface thereof for serving as a rail forsliding the disk along the arms (not shown).

In use, the inserter is held by one hand with portion 26 of handle 24resting against the palm and aims 28 held between finger and thumb nearthe location of disk 34. When adjustment of the relative position of thetube and the rod is required in order to withdraw the IUD into the tubeor to expose it, this can be easily done by gripping disk 36 betweenfinger and thumb and sliding it axially along arms 28 in the requireddirection. When the relative position between tube and rod should bekept fixed, i.e., when the IUD is inserted through the cervix, the armsare pressed by finger and thumb against recesses 38 to lock sleeve 3onto plunger 2, thus preventing possible relative movement between tube32 and rod 21 and maintaining the IUD in its contracted configuration atthe top of tube 32 as depicted in FIG. 5B. Arms 28 include markings 25which mark the correct position of disk 34 when the inserter and IUD areready for insertion.

It will be appreciated that the inserter of the present invention hasthe advantage of allowing the physician to manipulate both plunger andtube by one hand during the whole insertion procedure while leaving hisother hand free to use other instruments or perform other operations asnecessary. It will further appreciated that inserter 10 further allowsfor easily disengaging the plunger part from the sleeve part, thusallows withdrawal of the inserter, after the FUD is correctly placed,not as a whole unit, but by parts, namely first the plunger then thesleeve, to ensure that the monitoring string of the IUD is not entangledwithin the inserter and to reduce the risk of withdrawing the IUD alongwith the inserter.

Inserter 10 is designed for the insertion of a T-shaped IUD thatcomprises a cylindrical contraceptive body, i.e., copper-bearing orhormone releasing body, and a pair of foldable arms. Inserter 10 can beused for the insertion of any IUD of this type, including Nova-T andLNG-20 (Mirena®). However, in accordance with the general objective ofthe invention to make insertion easier while minimizing discomfort andpain, there is also provided a new IUD directed at this objective. TheIUD of the invention, unlike known T-shaped frame IUDs, does notcomprise a vertical stem that runs through the contraceptive body, butrather the contraceptive body is suspended from the middle node betweenthe two transversal anus. The elimination of a central shaft allows forreducing the diameter of the contraceptive body, making insertioneasier. The absence of a central relatively rigid shaft further allowsfor greater flexibility of the body, resulting with reduced bleeding andpain.

FIGS. 3 and 4 depict two embodiments designated 4 and 5, respectively,of an intrauterine device of the invention. Both embodiments comprise apair of foldable resilient wings 44, 54 and a contraceptive body 42, 52suspended from the junction zone between the two wings. Wings 44, 54 areof substantially similar shape as of those of the Nova-T and Mirena®devices. The wings are made of one resilient piece having a junctionzone from which the two convex wings divert. In their expanded relaxedconfiguration, the wings are generally directed at opposite lateraldirections substantially perpendicularly to the elongated body andhaving their tips 46 directed downward. The wings can easily flex towardeach other around the junction where they meet and can reach a fullcontracted configuration to abut each other, as in FIG. 5B. Tips 46 areof substantially hemispherical shape forming a rounded leading end whenthe wings are pressed against each other in the contractedconfiguration. Preferably tips 46 are dimensioned to be slightly widerthan opening 31 of tube 32 such that when the IUD is withdrawn into tube32 they stop the IUD at the correct position and prevent it from beingwithdrawn deeper into the tube. The structure and flexibility of thewings insures that the device can easily adapt to the lateral dimensionsof the uterus and can easily respond to uterus contractions whileminimizing the pressure applied on the uterus walls. In accordance withthe embodiments shown in FIGS. 3 and 4, the wings comprise an eyelet 45,55, respectively, in the junction zone between the wings.

In the embodiment depicted FIG. 3, body 42 is provided with twoextensions 42 a and 42 b at the upper and bottom ends, respectively,which comprise eyelets 43 and 41. In accordance with this embodiment,wings 44 and body 42 are connected by a flexible string 47 which isthreaded first through one of eyelets 45 and 43 and is tied to form afirst knot, then is threaded and tied around the second eyelet to form asecond knot and loop. The ends of the string can be cut close to theknots. A second string 48 is tied to bottom eyelet 41. String 48 is usedfor monitoring the IUD and to facilitate its removal. Body 42, whichcarries the contraceptive agent, may be a reservoir of contraceptivecompound such as levonorgestrel or any other suitable progesteroneanalog. Body 42 may comprise a core of suitable polymeric matriximpregnated with the contraceptive agent and enveloped by a permeablemembrane for controlling sustained release of the contraceptive agentinto the uterus cavity over a prolonged time. Alternatively, body 42 maycomprise a core enveloped with copper. Extensions 42 a and 42 b of body42 may be formed as part of the envelope. It will be appreciated thatbody 42 may contain other or additional active therapeutic agents fortreating various conditions of the uterus.

In the embodiment depicted in FIG. 4, only one string 56 is used forboth connecting wings 54 to body 52 and as the monitoring and removalstring. In accordance with this embodiment string 56 is inserted throughthe body substantially along its central longitudinal axis and is tiedaround eyelet 55. String 56 is inserted through body 52 either through apre-fabricated channel that runs from top to bottom or by forcing thestring through the resilient body by means of a needle-like instrument.The two ends of the string extending from the bottom end of body 52 aretied close to the body and serve for monitoring and removing the IUD. Inaccordance with the embodiment shown here, both ends of the string areinserted through the body, however it will be easily realized thatalternatively only one end of the string may be inserted through thebody such that the two ends of the string are extending from theopposites ends of the body, one end is tied to the wings while the otherend is tied on itself to form a knot close to the body and is left toserve as the removal string. Body 52 may be of the type described abovein association with FIG. 3, or alternatively may comprise copper ringsor copper wire surrounding the string.

FIGS. 5A to 5C demonstrate the relative position of the tube, plungerand the IUD during storage (5A); immediately before insertion (5B); andimmediately after the IUD is positioned in the uterus and before theinserter in withdrawn (5C).

During storage, the intrauterine device and the inserter are kept as akit under sterilized sealed packaging. The package is opened a shorttime before the insertion and only after examination to determine thesize, position, and curvature of the uterus.

As depicted in FIG. 5A, the packaged kit preferably contains inserter 10in the assembled configuration and with the contraceptive elongated body42 of IUD 4 inside the forward end of tube 32, protected thereby. Duringstorage, wings 44 must be stored in the expanded configuration in orderto prevent fatigue which might cause the wings to lose theirflexibility. If the IUD is retained in the tube with its wings foldedfor a prolonged period, permanent deformation might occur and the armsmight not return to their expanded configuration when released from thetube. At this position, i.e., with the IUD body protected inside tube 32and wings 44 outside tube 32, tube 32 is mounted near the free ends ofarms 28 and the tip 21 of plunger rod 22 does not contact the IUD but islocated at certain distance below it.

FIG. 2B demonstrates the inserter and the IUD ready for insertion. Atthis configuration, wings 44 are withdrawn into tube 32 to assume theircontracted configuration and the tip of plunger rod 22 contacts thebottom end of the IUD. To achieve this configuration, disk 34, heldbetween finger and thumb, is retracted on arms 28 toward the handleand/or the handle is pushed forward until disk 34 is positioned on marks25. At this configuration the IUD is entirely housed within tube 32 butfor tips 46 which are exposed, and is ready for insertion. As mentionedabove, tips 46 stop the ND from being withdrawn further into the tube.

To place the IUD, the inserter as configured in FIG. 5B is insertedthrough the cervical canal into the uterus while pressing arms 28inwardly against disk 34 to maintain the IUD in its contractedconfiguration within tube 22. When the IUD is in the correct position itis released from tube 22 by retracting disk 34 backward along arms 28until it reaches handle 24 and cannot be further moved. FIG. 5Cillustrates the configuration of the IUD and the inserter after release.The distance between marks 25 and the bottom end 27 of arms 28substantially equals the length of the IUD in its contractedconfiguration.

After the IUD is correctly placed inside the uterus, inserter 10 may bewithdrawn. In accordance with the invention withdrawal of the device maybe performed by first withdrawing the plunger part, then withdrawing thesleeve part. Such a procedure reduces the risk that removal string 48will get entangled between the sleeve and the plunger which might resultin the IUD being displaced or accidentally removed along with theinserter. In order to remove the plunger, disk 34 may be held steadywhile handle 24 is pulled backward until aims 28 are released from thedisk and the plunger can be removed. Thereafter the sleeve part may bewithdrawn.

It will be realized that the inserter of the invention may be used forthe insertion of any type of T-shaped IUD while the IUD of the inventionmay be positioned by means of any other suitable inserter. However, thecombination of the novel inserter and IUD of the invention providescertain advantages with respect to ease and simplicity of insertion,such as smaller diameter and more frontal flexibility, as well as withrespect to simplicity and cost of manufacturing.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather the scope of the present invention isdefined only by the claims which follow.

1. A combination of an intrauterine device and an inserter for placing the intrauterine device inside a patient's uterus, comprising: a T-shaped intrauterine device comprising an elongated contraceptive body and a transverse member comprising a pair of wings attached to one end of said body, the intrauterine device has a relaxed configuration in which said wings are extended laterally and a contracted configuration in which said wings are folded against each other; and an inserter for positioning a T-shaped intrauterine device in a patient's uterus, the inserter comprising a sleeve part and a plunger part; said sleeve part comprising a tube having two open ends and a first engaging member, said tube is dimensioned to receive said the intrauterine device in the contracted configuration through one of said two open ends; and said plunger part comprising a rod, a handle attached to one end of the rod and a second engaging member; said first and second engaging members are configured for reversibly and slidably engaging said sleeve part and said plunger part when the rod is inserted through the other open end of the tube and to temporarily lock the relative position between the tube and the rod.
 2. The combination of claim 1 wherein said first engaging member comprises a disk attached to the other open end of the tube, the disk having a central opening aligned with said other open end and two opposite recesses, and wherein said second engaging member comprises two resilient arms dimensioned to be received in said two opposite recesses.
 3. The combination of claim 1 wherein said sleeve part and said plunger part when disengaged can be separated into two separate parts.
 4. The combination of claim 1 wherein said elongated contraceptive body comprises a reservoir of at least one contraceptive agent and a sustained release means adapted for providing a sustained release of said at least one contraceptive agent.
 5. The combination of claim 1 wherein said elongated contraceptive body of said intrauterine device is suspended from said transverse member.
 6. The combination according to claim 5 wherein the contraceptive body is suspended by means of a string connected to a junction zone between the two wings.
 7. The combination according to claim 6 wherein said string is connected to said one end of the elongated contraceptive body.
 8. The combination according to claim 6 wherein said string is running along a central longitudinal axis of said elongated contraceptive body.
 9. The combination of claim 1 wherein the IUD further comprises at least one removal string suspended from the bottom end of the contraceptive elongated body.
 10. A kit for the positioning of an intrauterine device inside a patient uterus, the kit comprising the combination of claim 1 under sterile packaging.
 11. An inserter for positioning a T-shaped intrauterine device in a patient's uterus, the inserter comprising a sleeve part and a plunger part; said sleeve part comprising a tube having two open ends and a first engaging member, said tube is dimensioned to receive said elongated contraceptive body of the intrauterine device through one of said two open ends; and said plunger part comprising a rod, a handle attached to one end of the rod and a second engaging member; said first and second engaging members are configured for reversibly and slidably engaging said sleeve part and said plunger part when the rod is inserted through the other open end of the tube and to temporarily lock the relative position between the tube and the rod.
 12. The inserter of claim 11 wherein said first engaging member comprises a disk attached to the other open end of the tube, the disk having a central opening aligned with said other open end and two opposite recesses, and wherein said second engaging member comprises two resilient arms dimensioned to be received in said two opposite recesses.
 13. The inserter of claim 11 wherein said sleeve part and said plunger part when disengaged can be separated into two separate parts.
 14. A T-shaped intrauterine device comprising: a transverse member comprising a pair of wings, the wings having a relaxed configuration in which the wings extended laterally and a contracted folded configuration in which the wings are folded against each other; and an elongated contraceptive body suspended from said transverse member.
 15. The T-shaped intrauterine device according to claim 14 wherein said elongated contraceptive body comprises a reservoir of at least one contraceptive agent and a sustained release means adapted for providing a sustained release of said at least one contraceptive agent.
 16. The T-shaped intrauterine device according to claim 15 wherein said at least one contraceptive agent is a progesterone analog.
 17. The T-shaped intrauterine device according to claim 14 wherein the contraceptive body is suspended by means of a string connected to a junction zone between the two wings.
 18. The T-shaped intrauterine device to claim 17 wherein said string is connected to one end of the elongated contraceptive body.
 19. The T-shaped intrauterine device according to claim 17 wherein said string is running along a central longitudinal axis of said elongated contraceptive body. 